Article(id=1321425599197987648, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.07.006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1757260800000, acceptedDateStr=2025-09-08, onlineDate=1792982013748, onlineDateStr=2026-10-26, pubDate=1776182400000, pubDateStr=2026-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982013748, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982013748, creator=13701087609, updateTime=1792982013748, updator=13701087609, issue=Issue{id=1321425569611362746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='7', pageStart='673', pageEnd='784', issueExtLink='null', onlineDate='null', pubDate='1776182400000', pubDateStr='2026-04-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982006695, creator='13701087609', updateTime=1792983136833, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430309837587328, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430309837587329, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=710, endPage=721, ext={EN=ArticleExt(id=1321425600972178242, articleId=1321425599197987648, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Current status and considerations on the control of ethylene glycol, diethylene glycol, and triethylene glycol impurities in pharmaceutical excipients, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This article provides an in-depth exploration of the current quality control status and regulatory developments concerning ethylene glycol, diethylene glycol, and triethylene glycol impurities in pharmaceutical excipients. Since the 1940s, global public safety incidents caused by the misuse or contamination of ethylene glycol or diethylene glycol have occurred frequently, drawing significant attention from regulatory authorities worldwide. Regulatory agencies have introduced corresponding measures to prevent the recurrence of such incidents. The article details the sources, uses, safety profiles of ethylene glycol, diethylene glycol, and triethylene glycol, as well as their respective pharmacopoeial standards and the current regulatory landscape. Testing for the presence of these three impurities in representative excipient products has revealed potential risks posed by ethylene glycol, diethylene glycol, and triethylene glycol in pharmaceutical excipients. Based on these findings, the article proposes recommendations for strengthening detection standards, enhancing regulatory oversight, and improving safety assessments to ensure the safety of pharmaceutical excipients and prevent similar pharmaceutical disasters. The results indicate that establishing rigorous detection methods and standards for these three impurities is crucial for ensuring the overall quality and safety of pharmaceuticals, especially in the quality control of excipients, which should be given equal importance as that of active pharmaceutical ingredients.

, authors=Jue WANG¹, Xiao-feng WANG¹, Xue-yan ZHANG¹, Xia ZHAO¹, Bao-ming NING¹, Xiao LING³, Jia-sheng TU⁴, Rui YANG¹, Jun ZHANG^{2, *}, Hui-min SUN^{1, *}, authorsList=Jue WANG, Xiao-feng WANG, Xue-yan ZHANG, Xia ZHAO, Bao-ming NING, Xiao LING, Jia-sheng TU, Rui YANG, Jun ZHANG, Hui-min SUN, authorCompany=null, correspAuthors=Jun ZHANG, Hui-min SUN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1321425601240613699, articleId=1321425599197987648, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=药用辅料中乙二醇、二甘醇和三甘醇杂质控制现状和思考, columnId=1236330553964810454, journalTitle=中国新药杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

本文深入探讨了药用辅料中乙二醇、二甘醇和三甘醇杂质的质量控制现状及其监管动态。自20世纪40年代以来，全球范围内因乙二醇或二甘醇误用或污染而引发的公众安全事件频发，引起了全球药品监管机构的密切关注。各监管机构纷纷出台相应举措，以避免类似药害事件的再次发生。本文详细阐述了乙二醇、二甘醇和三甘醇的来源、用途、安全性及各国药典标准和药品监管部门管理现状。通过对代表性辅料产品中上述3种杂质含量检测，揭示了乙二醇、二甘醇和三甘醇在药用辅料中潜在的风险。基于此，本文提出强化标准制定、加大监管力度、完善安全性评估等举措，旨在确保药用辅料及其供应链的安全性，避免类似药害事件的重演。研究结果表明，构建3种杂质严格的检测方法和标准对于保障药品整体质量与安全性具有关键意义，尤其在辅料质量控制层面，应给予与原料药同等程度的重视。

, authors=王珏¹, 王晓锋¹, 张雪妍¹, 赵霞¹, 宁保明¹, 凌霄³, 涂家生⁴, 杨锐¹, 张军^{2, *}, 孙会敏^{1, *}, authorsList=王珏, 王晓锋, 张雪妍, 赵霞, 宁保明, 凌霄, 涂家生, 杨锐, 张军, 孙会敏, authorCompany=null, correspAuthors=张军, 孙会敏, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=32m8Cc56mGRA43FzrGoqqg==, magXml=coabQ3SH2wyr9sH4HKyOvg==, pdfUrl=null, pdf=1s1fDHr9CAjW58EvB9+hmg==, pdfFileSize=3861998, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=+otUGOzDuk7COsWeYYVFnA==, mapNumber=null, fund=null)}, authors=[Author(id=1321425601811039057, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425599197987648, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=wangjue2020@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425601894925139, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425599197987648, authorId=1321425601811039057, language=EN, stringName=Jue WANG, firstName=Jue, middleName=null, lastName=WANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹Key Laboratory of Quality Research and Evaluation of Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425601966228308, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425599197987648, authorId=1321425601811039057, language=CN, stringName=王珏, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹国家药品监督管理局药用辅料质量研究与评价重点实验室/中国食品药品检定研究院，北京 100050, bio={"content":"

王珏，女，研究方向：药用辅料质量控制和制剂应用。联系电话：（010）67095126，E-mail: wangjue2020@nifdc.org.cn。

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王珏，女，研究方向：药用辅料质量控制和制剂应用。联系电话：（010）67095126，E-mail: wangjue2020@nifdc.org.cn。

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